A Phase 2a, Double-blind, Randomized, Placebo-controlled, Proof of Concept Study of Vascular Endothelial Growth Factor (VEGF)-B Blockade with the Monoclonal Antibody CSL346 in Subjects with Diabetic Kidney Disease

  • STATUS
    Recruiting
  • sponsor
    CSL Behring LLC
Updated on 12 October 2021

Summary

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, proof of concept study to investigate the efficacy, safety, tolerability, and pharmacokinetics (PK) of repeat doses of CSL346 in 100 subjects with DKD and albuminuria receiving standard of care treatment.

Description

Our site is taking part in the MANEUVER research study for people with Diabetic Kidney Disease (DKD) due to Type 2 Diabetes. This study is testing an investigational drug called CSL346 to see if it is safe and effective in treating DKD when added to the standard medicines you take. About 100 participants will join the study at approximately 40 research sites in Australia, New Zealand, and the United States.

The study consists of about 11 visits to our site over about 8 months for testing and monthly study drug injections. All study-related office visits, medical procedures, laboratory tests, and study drug are provided at no cost to qualified participants. Reimbursement for study-related time and travel may be provided; ask the study staff if this is available.

Other requirements will be reviewed with you to determine if you may qualify.

Details
Condition Diabetic Kidney Disease
Clinical Study IdentifierTX284445
SponsorCSL Behring LLC
Last Modified on12 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Are at least 25 years old
Have Type 2 Diabetes Mellitus and DKD
Have been taking certain medications for hypertension (high blood pressure) and for your kidneys for at least the past 2 months
Have NOT had chronic dialysis or kidney transplant
Have NOT had heart disease or heart surgery in the past 6 months
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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